CN107430139A - Automatic analysing apparatus and automatic analysis method - Google Patents
Automatic analysing apparatus and automatic analysis method Download PDFInfo
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- CN107430139A CN107430139A CN201680016754.3A CN201680016754A CN107430139A CN 107430139 A CN107430139 A CN 107430139A CN 201680016754 A CN201680016754 A CN 201680016754A CN 107430139 A CN107430139 A CN 107430139A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
- G01N21/272—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration for following a reaction, e.g. for determining photometrically a reaction rate (photometric cinetic analysis)
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- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/82—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a precipitate or turbidity
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- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
- G01N33/4905—Determining clotting time of blood
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- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
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- G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
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- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
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- G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
- G01N35/1011—Control of the position or alignment of the transfer device
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Abstract
Present invention offer is a kind of can to make that the analytical equipment prepared automatically and method will be realized for examination blood plasma and the pooled plasma that normal plasma mix with defined mixing ratio.Automatic analysing apparatus (100) possesses:Sample dispensing mechanism (101), it dispenses the normal plasma added for examination blood plasma and/or to correct the setting time for trying blood plasma to multiple sample containers (103);Reaction vessel (104), it is used for housing for examination blood plasma and/or normal plasma;Reagent dispensing mechanism (106), it dispenses reagent to reaction vessel (104);And detection unit (113), it for examination blood plasma and/or normal plasma after reagent is with the addition of in reaction vessel (104) to irradiating the light from light source (115), and the scattering light based on acquisition and/or transmission light measurement setting time.Sample dispensing mechanism (101) will be configured to pooled plasma only for trying blood plasma, only normal plasma and being dispensed so that at least one kind of mixing ratio is mixed for examination blood plasma and normal plasma into multiple sample containers (103).
Description
Technical field
The present invention relates to it is a kind of to the biological samples such as blood, urine carry out qualitative and quantitative analysis automatic analysing apparatus, especially
It is to be related to the automatic analysing apparatus and automatic analysis method that a kind of solidification suitable for blood and hemostasis check.
Background technology
The purpose of blood clotting inspection is the morbid state of assurance blood clotting fibrinolytic system, (dispersivity is intravascular by diagnosis DIC
Blood coagulation), confirm thrombus treatment effect and diagnosis hemophilia.Especially, blood coagulation time measure is to mix sample and reagent
Close, determine the time (hereinafter referred to as blood coagulation time) untill fibrin clot is formed, appearance is congenital, posteriority is different
Chang Shi, blood coagulation time can extend.
But only determine blood coagulation time and can not differentiate that its reason is due to a lack of living caused by blooc coagulation factor
Property reduce (deficient) or because antibody for form blood clotting system composition or blood coagulation time measure reagent in
Activity reduces caused by the blood coagulation reaction of composition etc. suppresses (suppression formulation).
On the other hand, in the treatment, it is deficient according to the extension reason of blood coagulation time or suppresses formulation, treats policy
Can be different, it is therefore necessary to its clear and definite reason.
The method of the reason for as differentiating the extension of blood coagulation time, have by adding normal plasma to carry out
Cross-mixing experiment (Cross mixing test) (also referred to as blood clotting correction test or cross-mixing experiment).Intersect mixed
Close in experiment, normal plasma can be added in for examination blood plasma, and the degree of correction of the blood coagulation time is depicted as chart and entered
Row judges.The judgement for the extension factor that the most representational use example of cross-mixing experiment is APTT, but sometimes also can be at it
He is PT (prothrombin time), dPT (dilution PT), dAPTT (dilution APTT), KCT (kaolin clotting time) and dRVVT
Implement in projects such as (dilution russell's viper venom times).
But even if APTT is the main project that can implement in the most facilities for implementing blood clotting inspection, but it is existing
It is being difficult frequent implementation cross-mixing experiment.When can not implement in facility and need outside ministries and commissions' support object delegate inspection, need
Spend more time to obtain result, therefore for serious diseases such as hemophilia, the state of an illness can be resulted in a finding that and start to treat
Delay.The reason for producing such a situation is that the preparation of sample and the explanation of culture operation complexity and its result are also and unclear
Chu, it is therefore desirable to skilled examiner.
In order to solve the above problems, it is proposed that patent document 1.In patent document 1, for only for examination blood plasma, only normal blood
Slurry and the sample (pooled plasma) that will be mixed with least one kind of mixing ratio for examination blood plasma and normal plasma determine blood respectively
Liquid setting time, calculate by the measured value obtained draw below the line chart that forms product (A) with will only for examination blood plasma with only
The difference of product (B) below the straight line that the measured value of normal plasma is formed by connecting, and to area ratio (A-B)/(B) of the difference with
Defined reference area is compared than Y, based on comparative result, is determined that it is and is suppressed formulation or shortage type.
Prior art literature
Patent document
【Patent document 1】WO2009/153964 publications
The content of the invention
The technical problems to be solved by the invention
But the method for making the mixing for examination blood plasma and normal plasma realize automation is not disclosed in patent document 1,
When being prepared using manual methods, the mixed of acquisition may be made due to the complication of operation or the proficiency of operating personnel
Deviation be present in the precision for closing the mixing ratio of blood plasma.
Therefore, present invention offer is a kind of can make what will be mixed with defined mixing ratio for examination blood plasma with normal plasma
Pooled plasma realizes the automatic analysing apparatus and automatic analysis method prepared automatically.
Solves the technical scheme of technical problem
In order to solve above-mentioned problem, automatic analysis apparatus of the present invention is characterised by possessing:Sample dispenses mechanism, its
The normal plasma added for examination blood plasma and/or to correct the setting time for examination blood plasma is dispensed to multiple samples and held
Device;Reaction vessel, it prepares only described for examination blood plasma, only described normal plasma and with least one kind of in the sample container
The pooled plasma mixed for trying blood plasma and normal plasma is utilized dispensing institute of sample dispensing mechanism by mixing ratio
State confession examination blood plasma, the normal plasma and the pooled plasma being formulated;Reagent dispenses mechanism, and it divides reagent
Note to the reaction vessel;And determination part, it is to the addition of the described for examination blood plasma, normal blood of reagent in the reaction vessel
The light of slurry and/or pooled plasma irradiation from light source, and the scattering light based on acquisition and/or transmission light measurement setting time.
In addition, the automatic analysis method of the present invention is characterised by, dispensing mechanism using sample will be for trying blood plasma and/or being
The normal plasma for correcting the setting time for examination blood plasma and adding is dispensed to multiple sample containers, and in the sample container
Interior preparation is only described to supply to try blood plasma and normal blood for examination blood plasma, only described normal plasma and with least one kind of mixing ratio by described
The pooled plasma mixed is starched, by confession examination blood plasma, the normal plasma and the mixing blood being formulated
Slurry is housed into reaction vessel, while is dispensed reagent into the reaction vessel using reagent dispensing mechanism, to described
The light from light source for examination blood plasma and/or normal plasma irradiation of reagent is with the addition of in reaction vessel, and based on acquisition
Scatter light and/or transmission light measurement setting time.
Invention effect
In accordance with the invention it is possible to provide one kind can make with defined mixing ratio will for examination blood plasma be mixed with normal plasma and
Into pooled plasma realize the automatic analysing apparatus and automatic analysis method prepared automatically.
Problem, structure and effect other than the above can be according to the explanations of implementation below come clearly.
Brief description of the drawings
Fig. 1 is the overall schematic configuration diagram of the automatic analysing apparatus of the embodiment 1 involved by one embodiment of the present invention.
Fig. 2 is the skeleton diagram of cross-mixing experiment.
Fig. 3 is the flow chart for the handling process for showing the automatic analysing apparatus shown in Fig. 1.
Fig. 4 is the display example of operation screen when entrusting cross-mixing experiment measure.
Fig. 5 is the display example of operation screen when entrusting cross-mixing experiment measure.
Fig. 6 is to show the figure using state during sample dispensing mechanism suction normal plasma.
Fig. 7 is the figure for showing using the mechanism suction of sample dispensing state during for examination blood plasma.
Fig. 8 is the figure for showing state during using sample dispensing mechanism discharge normal plasma or for examination blood plasma.
Fig. 9 is the figure for showing the state that blood plasma is stirred using rabbling mechanism.
Figure 10 is the figure for the cross-mixing result of the test for showing the automatic analysing apparatus progress using embodiment 1.
Figure 11 is the overall schematic configuration diagram of the automatic analysing apparatus of the embodiment 2 involved by the other embodiment of the present invention.
Figure 12 is the explanation figure of the conveyance order of sample rack in automatic analysing apparatus shown in Figure 11.
Figure 13 is the explanation figure of the conveyance order of sample rack when cross-mixing is tested in automatic analysing apparatus shown in Figure 11.
Figure 14 is the explanation figure of sample dispensing position when cross-mixing is tested in automatic analysing apparatus shown in Figure 11.
Figure 15 is the stream of the handling process for the automatic analysing apparatus for showing the embodiment 3 involved by the other embodiment of the present invention
Cheng Tu.
The display example of operation screen when Figure 16 is the commission cross-mixing experiment of embodiment 3.
Figure 17 is the stream of the handling process for the automatic analysing apparatus for showing the embodiment 4 involved by the other embodiment of the present invention
Cheng Tu.
Figure 18 is the timing diagram of the action for the automatic analysing apparatus for showing embodiment 4.
Figure 19 is the stream of the handling process for the automatic analysing apparatus for showing the embodiment 5 involved by the other embodiment of the present invention
Cheng Tu.
Figure 20 is the stream of the handling process for the automatic analysing apparatus for showing the embodiment 6 involved by the other embodiment of the present invention
Cheng Tu.
The display example of operation screen when Figure 21 is the commission cross-mixing experiment of embodiment 6.
Figure 22 is to show only normal plasma, the figure only for trying blood plasma and the pooled plasma mixed according to 5 kinds of mixing ratios.
Figure 23 is to show only normal plasma, the figure only for trying blood plasma and the pooled plasma mixed according to 3 kinds of mixing ratios.
Figure 24 is to show only normal plasma, the figure only for trying blood plasma and the pooled plasma mixed according to a kind of mixing ratio.
Embodiment
In this specification, include being in hospital " for examination blood plasma " or the blood of the subject such as the blood plasma of out-patient and Gernral Check-up
Slurry.In addition, in this specification, as " normal plasma ", " for examination blood plasma " and " the mixing blood mixed with various mixing ratios
The general designation of slurry ", it is referred to as being used for the sample for determining blood coagulation time sometimes.In addition, in this specification, " general sample " refers to
The sample of subject.
Fig. 2 is the skeleton diagram of cross-mixing experiment.Normal plasma is added in for examination blood plasma, and carries out mixed preparing, is made
The ratio of normal plasma is 0,10,20,50,80,90,100%, prepares so-formed sample, implements APTT measure.Draw
Measurement result (blood coagulation time) and the proportionate relationship of normal plasma, are made chart.As shown in Fig. 2 transverse axis is normal plasma
Ratio (%), the longitudinal axis are APTT (blood coagulation time).For example, during deficient shown in Fig. 2 solid line (a), by adding just
Normal blood plasma extends to correct APTT, is shown as downwardly convex pattern.On the other hand, when suppressing formulation, such as Fig. 2 solid line (b)
It is shown, also it is difficult to correct APTT extensions even if addition normal plasma, is shown as the pattern to raise up.But inhibitor for
The reaction of the VIII factor has time and temperature dependency, therefore in firm mixed reaction (hereinafter referred to as immediate reaction) not
The shape to raise up can be explicitly shown, cultivates in the reaction (hereinafter referred to as deferred reaction) after certain time, has at 37 DEG C
When can be shown as the shape that raises up.
Therefore, in cross-mixing experiment, it is proposed that while determine immediate reaction and deferred reaction.
Hereinafter, using brief description of the drawings embodiments of the present invention.
【Embodiment 1】
Fig. 1 is the overall schematic configuration diagram of the automatic analysing apparatus of the embodiment 1 involved by one embodiment of the invention.This
Place, the flow of basic blood clotting inspection is illustrated using Fig. 1, but be not limited to the example below.
Automatic analysing apparatus 100 substantially by sample dispense mechanism 101, sample disk 102, reagent dispense mechanism 106, reagent disc 107,
Reaction vessel storage unit 111, reaction vessel transport mechanism 112, detection unit 113, reaction vessel waste part 117, operating portion
118th, storage part 119 and control unit 120 are formed.
Sample dispensing mechanism 101 can aspirate the sample being housed in sample container 103, and be expelled to and be housed in reaction vessel
In the reaction vessel 104 of storage unit 111, the sample container 103 is configured in clockwise and rotate counterclockwise sample disk 102.
The leading section of sample dispensing mechanism 101 possesses sample dispensing probe 101a, passes through the sample syringe pump controlled by control unit 120
105 action, perform the suction action and discharging operation of sample.
The reagent being housed in reagent container 108 aspirates in reagent dispensing mechanism 106, and is expelled to and is housed in reaction vessel storage
In the reaction vessel 104 for depositing portion 111, the reagent container 108 is configured in reagent disc 107.Reagent dispenses the leading section of mechanism 106
Possess reagent dispensing probe 106a, by the action by the reagent that control unit 120 controls with syringe pump 110, perform taking out for reagent
Suction action and discharging operation.
In addition, reagent dispensing mechanism 106 it is built-in reagent heating-up mechanism 109.The temperature of the reagent aspirated by reagent dispensing mechanism 106
Degree is warming up to proper temperature (defined temperature) by the reagent heating-up mechanism 109 controlled by control unit 120.
Reaction vessel transport mechanism 112 is implemented conveyance to the reaction vessel 104 for being housed in reaction vessel storage unit 111 and set
Put.Reaction vessel transport mechanism 112 is by gripping reaction vessel 104 and being rotated in the horizontal plane in arc-shaped, by reaction vessel
104 transport and are arranged at the reaction vessel setting unit 114 of detection unit 113 from reaction vessel storage unit 111.
Detection unit 113 has reaction vessel setting unit 114 more than at least one, and it is used for loading reaction vessel 104.
Detection unit 113 is to the sample measures luminous intensity in the reaction vessel 104 of intercalation reaction container setting unit 114.In addition, this implementation
In example, it is shown that the situation of 1 detection unit 113 of configuration, but can also be configured to that there are multiple detection units 113.Detection is single
The example of Cleaning Principle in member 113 is as described below.The light irradiated from light source 115 can be molten because of the reaction in reaction vessel 104
Liquid and scatter.Test section (light accepting part) 116 is made up of photodiode etc..Test section 116 is by receiving because of reaction vessel
Reaction solution (sample) in 104 and the scattering light that scatters simultaneously implement optical electrical conversion, will represent received scattering light
The light signal of intensity is exported to A/D converter 121.Implement the measure of the scattering light after A/D conversions by A/D converter 121
Signal can be inputted by interface 122 to control unit 120.The action of detection unit 113 is controlled by control unit 120.Herein, control
Portion 120 processed is made up of analysis operation control part 120a and operational part 120b.Analyze operation control part 120a and operational part 120b examples
Such as realized by CPU processor, by reading the various programs being stored in ROM or storage part 119 (not shown) and transporting
The read program of row, implements control and computing.
That is, analysis operation control part 120a control sample dispensing mechanisms 101 and sample disk 102, implement sample dispensing.This
Outside, analysis operation control part 120a also controls reagent dispensing mechanism 106 and reagent disc 107, and reagent is expelled into reaction vessel 104
Interior sample.Also, analysis operation control part 120a can also control the movement of reaction vessel 104, reaction vessel 104 it is discarded etc.
The action of automatic analysing apparatus.
Operational part 120b is based on basis and the degree of sample and the hybrid reaction of the reagent light intensity that accordingly time of origin changes
The comparative result of the signal value that the measured value of degree obtains and pre-determined decision threshold, implement measure processing, determine sample
Reaction time.The setting time calculated can be stored to storage part 119 while output is to display part 118c.In addition, also may be used
So that by interface 122, the setting time as result of calculation is printed out to printer 123.
The composition of test section 116 is not limited only to receive dissipate caused because of the reaction solution (sample) in reaction vessel 104
Penetrate light.For example, it is also possible to test section 116 is configured to transmission of the detection through the reaction solution (sample) in reaction vessel 104
The intensity of light.In addition it is also possible to using simultaneously using the test section of above-mentioned scattering light detection mode and transmitted light detection mode
116.Also, it in addition to the foregoing, can also use the detector 116 using viscosity.
Reaction vessel transport mechanism 112 grips the reaction vessel 104 after measure terminates, and is discarded to reaction vessel waste part
117。
In addition, in order to improve disposal ability, also it may be configured as, sample can be heated before addition determines beginning reagent and not have by possessing
There is the insulating box 124 of detector.
The analysis project for the sample analyzed by the use of automatic analysing apparatus 100 can be by being used as the keyboard 118b of input unit and showing
Show that the operation screen on display part 118c is inputted to control unit 120 from operating portion 118.Alternatively, it is also possible to being to use GUI
The composition of (Graphical User Interface, graphic user interface), the GUI can utilize the behaviour such as pointer by mouse 118a
Make the analysis project shown in display part 118c, input analysis project.
In addition, in Fig. 1, for the ease of showing all inscapes, labeled as reaction vessel storage unit 111, sample disk 102
And the separate configuration of reagent disc 107, but actually sample disk 102 is configured in composition sample dispensing with reaction vessel storage unit 111
In the range of the arc-shaped motion tracks of the sample dispensing probe 101a of mechanism 101 in the horizontal plane.In addition, reagent disc 107 with
Reaction vessel storage unit 111, which configures, is forming the circular arcs of the reagent dispensing probe 106a of reagent dispensing mechanism 106 in the horizontal plane
In the range of shape motion track.Therefore, during vertical view, these sample disks 102, reaction vessel storage unit 111 and reagent disc 107 are in
Roughly triangular shape configures.
Then, the commission of the cross-mixing experiment of the automatic analysing apparatus 100 of the present embodiment described further below and sample
Compound method.Fig. 3 is the flow chart for the handling process for showing the automatic analysing apparatus shown in Fig. 1, especially shows that commission intersects
The flow of sample compound method during bulk testing.
First, automatic analysing apparatus 100 accepts the commission (step S101) of cross-mixing experiment.The acceptance method of commission is divided into logical
Cross the mode received using the network system of master computer and entrust measure to accept from operating portion 118 by operator
The mode of the cross-mixing experiment measure commission inputted.One is used as below, illustrates to input measure commission by operation screen
Situation.
Fig. 4 and Fig. 5 represents to be shown in the display part 108c for forming operating portion 118 during commission cross-mixing experiment measure
The display example of operation screen.As shown in figure 4, cross-mixing experiment measure commission picture (operation screen) has the kind of display sample
Class is its region for which of general sample, urgent sample and management product.It is shown in Fig. 4 for general sample
Cross-mixing measure commission.In addition, cross-mixing measure commission picture (operation screen) have inspection project select/specify area
Domain 127.Operator can specify from inspection project selection/designated area 127 implements cross-mixing examination by the operation screen
The project tested.In example shown in Fig. 4, it is shown that selection specifies project APTT state.In addition, operation screen have it is optional
Select the region of specified normal plasma ratio.In example shown in Fig. 4, it is shown that the ratio of normal plasma is set as 0,10,20,
50th, the state of 80,90,100% this all 7 kinds of condition.In addition, the normal plasma ratio set herein is not limited only to shown in Fig. 4
7 kinds of conditions, as long as such as be set as more than 3 kinds of conditions containing 0%, 100%, i.e. only for examination blood plasma, only normal plasma with
And the pooled plasma mixed with least one kind of mixing ratio, other mixing ratios can arbitrarily be set.
As shown in figure 4, after setting measure project and normal plasma ratio, analysis operation control part 120a can calculate measure institute
Need normal plasma amount and for examination plasma volume, according to each condition determine respectively different normal plasma amounts and for examination plasma volume, and
Control the action of sample dispensing mechanism 101.Now, as shown in figure 5, by showing required normal plasma amount in display part 118c
With for trying plasma volume, operator is signaled to.When operator can hold required plasma volume, it can not only mitigate operator's calculating
The desired amount of burden, while the effect for preventing occurring plasma volume deficiency in the midway of preparation in advance can also be obtained.Herein, Fig. 5
Middle operator specifies normal plasma, for examination blood plasma, the set location of empty sample container, but is also controllable to device and specifies setting
Position.In addition, in Fig. 5, it is shown that the set location of normal plasma is set as into " 100 ", will be set for the set location for trying blood plasma
It is set to " 101 " and the starting position of empty sample container is set as to the state of " 102 ".Herein, each position represents sample disk
The position of sample container 103 in 102, not it is only capable of being specified with numeral, such as can be also referred to by letter with number combinatorics on words
Determine the position of sample container 103.
In addition, from when accepting commission using the network system of master computer, can need not setting measure project and condition determination
Analyzed.
Under the state shown in fig. 5, after pressing START button (step S102), normal plasma amount is confirmed, for trying blood plasma
Measure and whether there is sky sample container (step S103).Herein, empty sample container refers to have the disposable of individual identification media can
The container clogged.Individual identification media refer to the media for identifying sample, such as bar code or RFID etc. can be used.Subject
In the individual identification media of sample, in addition to the sample ID for identifying sample, also containing measure entrusted information etc..Paste
In individual identification media in empty sample container, be assigned with arbitrary numbers, for manage by normal plasma, for examination blood plasma mix and
Into pooled plasma.Confirm normal plasma amount, for examination the presence or absence of plasma volume and empty sample container when, sample dispensing machine can be utilized
The liquid level detection function of structure 101, dispense probe 101a contacts using the sample of the front end because being arranged on sample dispensing mechanism 101
Or the change close to liquid level and the electrical characteristic such as static capacity or resistance value for changing, detect liquid level.In addition, also it may make up
To be shot using the camera function (sensor such as CCD, CMOS, PMT) of miniature camera etc., being calculated according to liquid level
Liquid measure.By the use of the liquid level detection function of sample dispensing mechanism 101 and bar code is used to know as individual as an explanation below
The situation of other media.
With the rotation of clockwise and rotate counterclockwise sample disk 102, the subject for the position specified in Fig. 5 is arranged on
When sample and empty sample container are by before reading part 125, the individual identification media i.e. bar code of subject's sample can be read.It is right
Checked in the corresponding authorized item of subject's sample with being specified according to the bar code read, and will be set
The normal plasma ratio and original subject's sample information and the ID of each pooled plasma made in empty sample container is checked.
Then, as shown in fig. 6, the sample container 103a that normal plasma is filled with the sample container 103 in sample disk 102 is moved to
Sample dispenses the dispensing position of mechanism 101, and confirms normal plasma using sample dispensing probe 101a liquid level detection function
Amount.Similarly, the sample container 103b being filled with for examination blood plasma can be moved to dispensing position, and utilize sample dispensing probe
101a liquid level detection function, confirm the amount (Fig. 7) for examination blood plasma.And for empty sample container, probe is dispensed by sample
101a liquid level detection function, when not contacting and being contacted to the bottom of the sample container (abnormal to decline detection) with liquid level, know
Not Wei set sample container be empty.
In return Fig. 3, step S104, container sets the result checked for normal plasma amount, is not up to institute for examination plasma volume
Requirement or not assigned position set needed for number empty sample container when, stop the preparation of pooled plasma, and display system
Alarm (step S105).Therefore, it is possible to avoid measure midway from blood plasma deficiency occur or due to being not provided with sky sample container
The sample container that position has dispensed sample (normal plasma, for examination blood plasma or pooled plasma) dispenses and makes sample again
The risk that disk 102 pollutes.
In step S104, prepare more than aequum normal plasma amount, for examination plasma volume and confirmed empty sample container
There is provided during required number, start to the empty sample container dispensing normal plasma (step S106) of beginning.
Herein, the dispensing action of normal plasma is illustrated.With turning clockwise and the rotation of the sample disk of rotate counterclockwise 102,
The sample container 103a for being filled with normal plasma is moved to dispensing position, and sample dispensing mechanism 101 can aspirate normal blood
Starch (Fig. 6).In example shown in Fig. 6, it is shown that the situation of the stepped rotation counterclockwise of sample disk 102, the movement of each ladder
Spacing of the distance equivalent to 2 sample containers 103 being adjacent to.Therefore, read and pasted as described above using reading part 125
Bar code in sample container 103, after sample ID is identified, along the direction of rotation of sample disk 102, positioning is extremely located at reading part
The underface (sample dispensing position) of the sample dispensing mechanism 101 in 125 front.That is, each sample container 103 all the time can
After sample ID is identified by reading part 125, positioning to dispensing position.
Then, with the stepped rotation of sample disk 102, positioning to the sample container 103 of dispensing position is to be filled with confession
The sample container 103b (Fig. 7) of blood plasma is tried, therefore the sample dispensing probe 101a by forming sample dispensing mechanism 101 will not be discharged
The normal plasma pumped out.Then, sample container of the positioning to dispensing position is empty sample container 103c, can discharge and be pumped to sample
Normal plasma (Fig. 8) in this dispensing probe 101a.Repeat this action, by normal plasma dispense to empty sample container 103d~
103i.After the dispensing of normal plasma completes (step S107), the dispensing (step S108) for examination blood plasma is then carried out.
Dispensing action in step S108 for examination blood plasma is that, with the rotation of sample disk 102, will be filled with first for examination blood
The sample container 103b of slurry is positioned to dispensing position, and is supplied using the sample dispensing probe 101a suctions of sample dispensing mechanism 101
Try blood plasma (Fig. 7).Then, with the rotation of sample disk 102, positioning to the sample container of dispensing position is to arrange in step s 106
The sample container 103c of normal plasma is gone out.The blood plasma that supplies to try that sample dispenses probe 101a and will aspirated is expelled to sample container
103c (Fig. 8).According to same step, using sample dispense probe 101a will be dispensed for examination blood plasma to sample container 103d~
103i.All dispensings for examination blood plasma are repeated until completing (step S109).
In addition, in step S106 and step S108, probe 101a is dispensed to each sample from the sample for forming sample dispensing mechanism 101
The normal plasma of container 103c~103i discharges and the discharge rate for trying blood plasma are set with for example passing through the operation screen shown in Fig. 4
Normal plasma ratio it is corresponding.
Return to Fig. 3, in step S110, as shown in figure 9, using rabbling mechanism 126 will dispense in positioning to rabbling mechanism 126 just
Normal plasma in the sample container 103c of lower section for the pooled plasma of examination blood plasma with being stirred.Herein, rabbling mechanism 126
Such as by making rod of the front end provided with paddle or doctor-like infiltrate in the pooled plasma in sample container 103c simultaneously as shown in Figure 9
Rotated to implement to stir.In addition, rabbling mechanism 126 is not limited to the mode for rotating paddle or the rod of doctor-like.
For example, also may be configured as, ultrasonic wave is irradiated to the pooled plasma in sample container and is stirred.Adopted in addition, also may replace it
With the composition for making sample disk 102 positive and negative (turning clockwise, rotate counterclockwise) rotation or using by normal plasma or for examination blood
Starch from sample dispensing probe 101a be expelled to sample container 103 when discharge pressure, i.e. the discharge pressure of sample syringe pump 105
To be stirred the composition of blood plasma.
In this way, in the automatic analysing apparatus 100 of the present embodiment, sample can be utilized according to the operation screen shown in above-mentioned Fig. 4
This dispensing mechanism 101 and rabbling mechanism 126 prepare the pooled plasma with set various normal plasma ratios automatically.
In addition, in Fig. 3, using in dispensing normal plasma (step S106), dispensing supplies to try the knot of blood plasma (step S108) afterwards
Structure, but this is not limited to, it can also use and the composition that normal plasma prepares pooled plasma is dispensed after dispensing for examination blood plasma.This
Outside, it is contemplated herein that to normal plasma and the viewpoint of the pollution for examination blood plasma is prevented, using separated dispensing normal plasma and for examination blood
The composition of slurry, but it is not limited to this.For example, sample dispensing mechanism 101 is cleaned fully, also can be one during without concern of contamination
Individual making (preparation) pooled plasma.Now, the desired amount of normal plasma is dispensed to empty sample container 103c, dispenses aequum
For examination blood plasma.After the pooled plasma for making sample container 103c is made, pooled plasma is made successively according to each empty sample container,
To make empty sample container 103d pooled plasma.
In addition, during 2 kinds of samples of dispensing, it can also be shown at display part 118c in figure 3 at the end of step S109 and prepare knot
The picture of beam, and clogged by operator and add the sample container of the sample prepared and be stirred, then place again
Onto sample disk 102.Now, without possessing sample rabbling mechanism 126, therefore it is capable of the miniaturization of realization device.
After sample preparation terminates, 7 pooled plasmas prepared on 103c~103i are used to implement analysis.In addition, will be as
This measure that then sample preparation is implemented immediately is defined as instant type measure.In Fig. 3 step S111, read using reading part 125
Bar code is taken, the bar code, which is pasted, is housing the sample container 103c of 7 kinds of mutually different pooled plasmas of normal plasma ratio
On~103i, only normal plasma, only confession examination blood plasma, 5 kinds of mixing ratios i.e. 10,20,50,80,90% normal plasmas are respectively specified that
The pooled plasma of ratio, subsequently into step S112.In step S112, using sample dispensing, mechanism 101 will be housed in each sample
Sample in container 103c~103i is dispensed to the mutually different reaction vessel 104 being housed in reaction vessel storage unit 111.
Then, each reaction vessel 104 is moved to detection unit 113 using reaction vessel transport mechanism 112, as described above held reaction
Device 104 is placed to reaction vessel setting unit 114, and detects the light signal for the intensity for representing scattering light and/or transmitted light.This
Place, has following functions:Can be to the normal blood checked in the sample container identification step S103 of 7 samples prepared
Ratio and subject sample ID are starched, and is checked with measurement result.
But the difference in cross-mixing experiment with common analysis is, is calculated for subject's sample
Multiple (being herein 7) APTT setting times, and a chart is made, for diagnosing.Result after instant type measure terminates shows
Be shown as, for example, by such as Figure 10 solid line (a) Suo Shi using the normal plasma ratio of each pooled plasma as transverse axis, with APTT setting times
The chart formed, which is drawn, for the longitudinal axis is shown in operating portion 118c (step S113).By using indivedual identification media to measurement result
Checked and the automatic drafting function of chart, input error of the operator to measurement result can be prevented, and can carry
For the result with reliability.Now, preferably by interface 122 from the print result of printer 123.
After instant type measure, then implement during delaying type measure (step S114), the pooled plasma after instant type is determined
The container of (residual samples) clogs, and cultivates certain time at 37 DEG C.Culture is implemented in insulating box 124, but the structure of device
When not having insulating box 124 in, implement to cultivate outside device.It is described herein as in order to save the space of device and reduce cost,
Insulating box 124, and situation about being cultivated outside device are not set in a device.In device, to determine the end time as starting point,
Count incubation time.Now, operator is by presetting incubation time, at the end of culture can be known from operation screen
Carve.Furthermore it is preferred that the display (step S115) that output notice culture terminates when close to culture finish time.Therefore, operator
The situation of the sample in culture can be held, will not occur to forget measure.Operator is opened the pooled plasma for cultivating end
Bolt, and place to sample disk 102, press measure start button.Press measure start button after (step S116), with sample disk
102 rotation, read the pooled plasma ID for being arranged on the position specified in the operation screen shown in Fig. 5, and identification step S103
The middle normal plasma ratio checked and subject sample ID, are checked (step S117) with authorized item, implement delaying type
Determine (step S118).After measure terminates, the chart (step S119) of the delaying type shown in Figure 10 solid line (b) is made, and with
The result of instant type is checked (step S120).At this point it is possible to the chart of instant type and delaying type is synthesized one as shown in Figure 2
Zhang Tu, or can also shown separately mutually different 2 charts.
As it appears from the above, according to the present embodiment, making, the analysis of instant type/delaying type of pooled plasma can be implemented automatically
And the result verification of instant type/delaying type, therefore be not in the measurement result caused by the proficiency difference of operator
Deviation and artificially take wrong sample etc. slip up, can further improve reliability.
Additionally it is possible to mitigate the burden of operator, result is obtained rapidly.
Furthermore it is possible to realizing can make to realize for examination blood plasma and the pooled plasma that normal plasma mixes with defined mixing ratio
Automatically the automatic analysing apparatus and automatic analysis method prepared.
【Embodiment 2】
Figure 11 is the overall schematic configuration of the automatic analysing apparatus of the embodiment 2 involved by the other embodiment of the present invention
Figure.In the present embodiment, automatic analysing apparatus possess sample rack 201, sample rack supply unit 202, sample rack incorporating section 203, by sample
Transport to the carrying line 204 of analysis portion 210, the line of return 205, sample rack standby unit 206, standby unit operating mechanism for this 201
207th, sample rack gigback 208, the 1st reading part (carrying line) 209 and analysis portion 210.It is used for carrying that is, being used as
The mechanism of sample container 103, have and sample container 103 is mounted on sample rack 201 and transports the various conveyances of sample rack 201
This point of mechanism is different from embodiment 1.Other aspects are same as Example 1, therefore for inscape mark same as Example 1
Note same label, explanation omitted below.
As shown in figure 11, multiple analysis portions 210 can be connected along carrying line 204 by consisting of, but in the present embodiment, is configured to
Possesses at least one analysis portion for being used for implementing measuring clotting time.For implement the basic composition of the analysis portion 210 of measuring clotting time with
And fundamental analysis flow is roughly the same with embodiment 1, but sample is supplied by carrying line 204, therefore does not have sample disk
102。
Described further below and embodiment 1 has the supply method of the sample of larger difference.
In the automatic analysing apparatus of the present embodiment, the conveyer of the analysis portion 210 configured along carrying line 204 possesses:2nd reads
Portion's (analysis portion) 211, it is used for the analysis entrusted information for checking corresponding sample;1st sample rack operating mechanism 212, it is from conveyance
Line 204 receives sample rack 201;Line 213 is dispensed, it possesses the function that sample rack 201 can be made standby to dispensing start, and by sample
In this dispensing to the sample container of sample rack 201;Buffer region 214, it makes sample when preparing cross-mixing pooled plasma
Frame 201 is kept out of the way;And the 2nd sample rack operating mechanism 215, its sample rack 201 after sample is dispensed are transported to the line of return 205.
First, illustrate to implement sample when in general analyzes the i.e. analysis of calibration object, management product, general sample etc. using Figure 12
This supply flow is the conveyance order of sample rack.
When accepting analysis commission by operating portion 118, sample rack 201 on sample rack supply unit 202 is arranged in fig. 12, such as
After transferring load to carrying line 204 shown in arrow (a), read by the 1st reading part (carrying line) 209 and paste in sample rack 201 and receive
Hold to the individual identification media (such as bar code etc.) in the sample container in sample rack 201, and identify sample rack number and sample
This bin number (arrow (b) in Figure 12).Then, if having sample rack 201 in dispensing line 213, the 1st reading part is passed through
The sample that (carrying line) 209 is read, which can house, to sample rack standby unit 206, to be waited (arrow (c) in Figure 12) to be analyzed.Dispensing
The sample rack 201 that the stage of the sample dispensing end of line 213 is standby can be sent to analysis portion 210, pass through (the analysis of the 2nd reading part
Portion) 211 identification sample rack numbers and sample container number ((d) in Figure 12).Then, the 1st sample rack operating mechanism is passed through
212, dispensing line 213 ((e) in Figure 12) is drawn into, dispensing mechanism 101 by sample dispenses sample.Now, if dispensing line
There is no sample rack 201 on 213, then will not house to sample rack standby unit 206, but directly conveyance extremely dispensing line 213.
House sample dispensing mechanism 101 dispensing terminate after sample sample rack 201 can by the 2nd sample rack operation machine
Structure 215 is transported to the line of return 205 ((f) in Figure 12), and is transported by standby unit operating mechanism 207 to sample rack standby unit
206 ((g) in Figure 12).Herein, measurement result is waited, when being judged to not checking again for, passes through standby unit operating mechanism
207 transfer load to the line of return 205 ((h) in Figure 12), and transport to sample rack incorporating section 203 (Figure 12 (i)).
Figure 13 show cross-mixing experiment sample prepare in sample-feed flow, i.e. sample rack conveyance sequentially.
After accepting analysis commission by operating portion 118, the sample rack 201 that is arranged on sample rack supply unit 202 is removed transferring load to
After line sending 204 (arrow (a) in Figure 13), read by the 1st reading part (carrying line) 209 and paste in sample rack 201 and house
Individual identification media (such as bar code) in sample container in sample rack 201, identify sample rack number and sample container
Number ((b) in Figure 13)., can be to housing when confirming the commission that cross-mixing is tested by the 1st reading part (carrying line) 209
Normal plasma, the progress complete check of sample rack 201 for trying blood plasma and empty sample container, and housed to sample rack and treated
Machine portion 206 etc. is to be analyzed, until not having the sample (arrow (c) in Figure 13) in analysis on dispensing line 213.Now, house and supply
The sample rack of examination blood plasma, normal plasma and empty sample container can be all housed in same sample rack, can also cross over two
Individual sample above frame is housed.
There is no the sample in analysis on dispensing line 213 and house analysis object i.e. for examination blood plasma, normal plasma and empty sample
When the sample rack 201 of this container is firmly established, according to the sample rack for housing the confession examination blood plasma as analysis object, house
The order of the sample rack of empty sample container, transport to analysis portion 210.Then, sample is identified by the 2nd reading part (analysis portion) 211
This number and sample container number ((d) in Figure 13).Then, dispensing line is delivered to by the 2nd sample rack operating mechanism 215
213 ((e) in Figure 13), in the same manner as above-described embodiment 1, using under the liquid level detection function of sample dispensing mechanism 101, exception
Drop detection function, confirmation had been filled with it is the desired amount of for examination blood plasma, normal plasma and for prepare pooled plasma institute it is required
Sample container 103 for sky.
Herein, when setting incorrect for examination plasma volume, normal plasma amount and empty sample container, machine is operated by the 1st sample rack
After structure 212 is returning briefly to carrying line 204, by the 2nd sample rack operating mechanism 215, it can transport to the line of return 205, and return to sample
Behind this incorporating section 203, output system is alarmed and stops sample and prepares.
On the other hand, it is confirmed that for examination plasma volume, normal plasma amount and empty sample container, correct sample rack 201 is set
By the 1st sample rack operating mechanism 212 returning briefly to carrying line 204, and transported again by the 2nd sample rack operating mechanism 215
To dispensing line 213.The transported sample rack 201 of suction supplies examination blood plasma, then, is expelled to sky sample container.Now, empty sample
When container is housed on other sample racks, make sample rack configuration in the buffer region 214 on dispensing line 213, and pass through sample
The arc-shaped spinning movement of this dispensing mechanism 101 in the horizontal plane, is expelled to sky sample container (Figure 14).Repeat same move
Make, pooled plasma is made for examination blood plasma and normal plasma in dispensing.Now, the 126 preferred structure of rabbling mechanism shown in embodiment 1
Turn into:It is configured to be accessed on dispensing line 213, and the mixing of pooled plasma can be implemented.
The sample rack for housing the sample prepared returns to carrying line 204 by the 1st sample rack operating mechanism 212, and
The line of return 205 ((g) in Figure 13) is delivered to by the 2nd sample rack operating mechanism 215.Thereafter, the sample prepared is housed
Sample rack 201 by standby unit operating mechanism 207, be drawn into sample rack standby unit 206 ((h) in Figure 13), wait for
Analysis.Herein, as shown in figure 11, when analysis portion 210 does not have the construction of rabbling mechanism 126, machine is operated by the 2nd sample rack
Structure 215 delivers to the line of return 205 ((g) in Figure 13), and returns to sample rack incorporating section 203 ((g) in Figure 13).Operator is from returning
The sample prepared is reclaimed on the sample rack returned, and is placed to again on sample rack supply unit 202 after agitation, is implemented any
Project (such as APTT) analysis (measure of instant type).Due to analysis method similarly to Example 1, therefore omit the description.
The sample that analysis terminates delivers to the line of return 205 ((g) in Figure 13) by the 2nd sample rack operating mechanism 215, and returns
Return sample rack incorporating section 203 ((g) in Figure 13).Operator reclaims the sample for being back to sample rack incorporating section 203, at 37 DEG C
Implement culture certain time, and be placed to again on sample rack supply unit 202, implement the measure of delaying type.
According to the present embodiment, in addition to the effect of embodiment 1, additionally it is possible to by controlling the conveyance direction of sample rack, hold
Changing places, measure and delay determine immediately for implementation.
【Embodiment 3】
Figure 15 is the handling process for the automatic analysing apparatus for showing the embodiment 3 involved by the other embodiment of the present invention
Flow chart.In the present embodiment, the composition of automatic analysing apparatus itself can be using a certain in above-described embodiment 1 or embodiment 2
Individual composition, it replaces sample (making pooled plasma) that measure object is prepared in sample container, but by normal plasma and
It is different from embodiment 1 and embodiment 2 that this point is directly dispensed to the preparation of implementation measure object sample in reaction vessel for examination blood plasma.
That is, in the present embodiment, by adding examination again after directly being dispensed by normal plasma and for examination blood plasma to reaction vessel
Agent is implemented to determine, therefore with as shown in above-mentioned embodiment 1 and embodiment 2, utilizing other container mixing normal plasmas and for examination
Blood plasma, and after pooled plasma is made, in measure dispensing the method into reaction vessel again compares, the loss of sample compared with
It is few.
As shown in figure 15, first, automatic analysing apparatus accepts the commission (step of cross-mixing experiment by operating portion 118
S301).Then, in the same manner as above-described embodiment 1 and embodiment 2, (walked identifying that the START button shown in Fig. 5 is pressed
Rapid S302) before, it is same as Example 1.
As shown in figure 16, in the cross-mixing measure commission picture of the present embodiment, similarly to Example 1, by operator
To specify the selection of analysis project that normal plasma ratio set, inspection project select/carried out by designated area 127 to specify.
Herein, as shown in figure 16, in the present embodiment in addition to subject ID, normal blood can be inputted by being provided with also on operation screen
Starch the region of ID and the position for examination blood plasma/normal plasma.After pressing START button, pasting for examination blood plasma/normal blood
, can be with the rotation of sample disk 102, before by reading part 125 in the case of the individual identification media such as bar code of slurry
It is identified for the sample ID for trying blood plasma/normal plasma.When not pasting when sample ID reads failure or individual identification media, energy
Enough by supplying in the sample ID of examination blood plasma/normal plasma and the column of position to be manually entered to enter on Figure 16 operation screen
Row identification.In addition, when accepting commission by using the network system of master computer, measure project and measure bar can need not be set
Analyzed part.
After pressing start button (step S302), sample dispensing mechanism 101 can aspirate be arranged on it is normal on sample disk 102
Blood plasma, and dispense to reaction vessel 104 (step S303).Then suction is for examination blood plasma, and dispenses to (the step of reaction vessel 104
S304).Herein, it is shown that according to normal plasma, for try blood plasma order dispensed the step of, but these steps S303 and
S304 order may be reversed.In addition, after suction normal plasma, reaction vessel 104 can not also be expelled to, directly suction supplies
Blood plasma is tried, and concentrates and is expelled to reaction vessel 104.
If the measure is instant type measure (step S305), reaction vessel transport mechanism 112 can grip reaction vessel,
And it is moved to detection unit 113 (step S306).Then, reagent dispensing (step S307) is implemented using reagent dispensing mechanism 106
And examinations (step S308), it is repeated up to all samples of the normal plasma ratio set in the operation screen shown in Figure 16
Measure (S309) is completed, the chart (step S310) of instant type measurement result is drawn after the completion of measure.
, will when the measure of the reaction vessel is not instant type measure, when being delaying type measure in addition, in step S305
Reaction vessel 104 is moved to insulating box 124 (step S311), and stores heating start-up time.Repeat the operation picture shown in Figure 16
The preparation (step S312) of all pooled plasmas of the normal plasma ratio set in face, cultivates all pooled plasmas.Reaching
Heat the stage (step S313) of end time, reaction vessel transport mechanism 112 can grip reaction vessel 104, and reaction is held
Device 104 is moved to detection unit 113 (step S314).In the present embodiment, incubation time can be managed in automatic analysing apparatus,
Therefore can mitigate because of the deficiency of incubation time or due to exceeding and the risk of output error result.Herein, can be in operation screen
The middle display time, to know that cross-mixing experiment is implemented in culture.More preferably with when can flexibly set culture
Between function.Then, reagent dispensing (step S315), and examinations (step S316) are implemented using reagent dispensing mechanism 106.
All samples completion measure (step S317) until being prepared is repeated, delaying type measurement result is drawn after the completion of measure
Chart (step S318).
Then, in step S319, by the chart of the instant measurement result obtained by step S310 and step is passed through
The chart for the delaying type measurement result that S318 is obtained is checked, and is set to final result (step S319).
In this way, according to the present embodiment, by directly being dispensed to reaction vessel 104, and entirely by normal plasma and for examination blood plasma
The output of the preparation of pooled plasma, culture, measure and measurement result is automatically carried out, can be independent of the proficiency of operator
Ground provides the result of high reliability.Additionally it is possible to mitigate the negative of subject by reducing the sample size used in preparation
Load.
In addition, in the present embodiment, it is configured to can also to directly input and is filled with normal plasma and the sample container for examination blood plasma
Position, therefore be also applied in using without using the facility of sample ID management functions.
【Embodiment 4】
Figure 17 represents the handling process of the automatic analysing apparatus of the embodiment 4 involved by the other embodiment of the present invention.
The implementation of cross-mixing experiment is illustrated in 1~embodiment of embodiment 3, but automatic analysing apparatus not is only implemented to intersect to mix
Experiment is closed, is generally also used in solidify the ill assurance of fibrinolytic system, DIC (disseminated intravascular coagulation) diagnosis, thrombus
In inspection for the purpose of confirmation of therapeutic effect etc..That is, cross-mixing inspection pooled plasma complete culture and it is real
When applying delay type analysis, if being mixed with common analysis commission, the mixing blood of cross-mixing can be not necessarily analyzed immediately
Slurry.Therefore, in the automatic analysing apparatus of the present embodiment, with can be according to the work(of the priority of the categorizing selection inspection of sample
Can aspect and the difference of 1~embodiment of embodiment 3.
In the automatic analysing apparatus illustrated in the present embodiment, for corresponding blood clotting energy preoperative in clinical examination
Require swiftness when same day report of inspection result etc. is provided during the inspection of power or to outpatient, having can be prior to logical
Normal sample implements the function of analysis.Herein, it is desirable to which these swiftness samples, which are referred to as, is defined as urgent sample, and having can be excellent
Prior to the feature that general sample implements analysis.On the other hand, trained due to being managed in the pooled plasma for cross-mixing inspection
The foster time, it is expected to be measured immediately when terminating the culture of certain time so requiring.Therefore, energy is illustrated using Figure 17
Enough demands according to operator select priority according to sample classification, and the processing of measure order is determined according to priority.Figure 17
In, in case of by priority level initializing for " urgent sample measures > delaying types cross-mixing tests the general sample measures of > "
Illustrate, but the setting of priority is not limited to this mode.
For the pooled plasma made for delaying type cross-mixing culture at the end of (step S401), device is not
Can be according to below scheme (step S402) during holding state.Commission (the step of urgent sample is whether there is in the project of decision plan
Enter step S406 when S403), without the commission of urgent sample, re-start scheduling so that compared with the commission of general sample,
It is preferential to implement delaying type cross-mixing experiment (step S406).But when having entrusted the analysis of urgent sample, it is first according to urgent
Sample, cross-mixing experiment, the order of general sample implement analysis, therefore in the analysis of urgent sample, can make cross-mixing
Pooled plasma is temporarily standby in insulating box 124 (step S404).When the analysis of urgent sample is completed (step S405), weight
Newly it is scheduled so that preferential to implement delaying type cross-mixing experiment (step S406) compared with the commission of general sample.This
Place, for the pooled plasma made for delaying type cross-mixing culture at the end of (step S401), if device is in
Holding state is discussed further below starting the analysis of cross-mixing experiment then without being scheduled as described above.
First, make to be moved to detection unit 113 from insulating box 124 for the pooled plasma that delaying type cross-mixing makes
(step S407).Then, reagent (step S408), and examinations (step S409) are dispensed to the pooled plasma prepared.Weight
Multiple implementation steps S407~step S409 processing, until owning for the pooled plasma prepared for delaying type cross-mixing
Analysis terminates.After the completion of the analysis of pooled plasma (step S410), the result (step of simultaneously output cross bulk testing is calculated
S411)。
Then, it is surplus have the commission of general sample when (step S412), analyze general sample (step S413), general sample
Analysis after the completion of (step S414), automatic analysing apparatus can turn into holding state (step S415).
Figure 18 is the timing diagram for the action for showing the automatic analysing apparatus shown in Figure 17.As shown in figure 18, automatically analyzing
When device itself is holding state, after accepting the measure commission of general sample, automatic analysing apparatus, which can turn into, to be used for determining typically
The running status of sample.Now, it is assumed that, then can be in advance as described above by urgent sample after accepting the measure commission of urgent sample
The priority level initializing of measure processing is highest, is determined followed by cross-mixing experiment with the delaying type of sample (pooled plasma), one
As sample measure priority level initializing to be minimum.Therefore, urgent sample process can preferentially be implemented.Urgent sample process is completed
Afterwards, start again in general sample process, if the incubation time of cross-mixing experiment pooled plasma terminates, can temporarily in
The processing of disconnected general sample, and start delaying type measure.Implement in delaying type measure, accepted the measure commission of urgent sample
When, even if the priority level initializing of urgent sample process is higher, urgent sample process also can turn into holding state until delaying type
Measure terminates, and after cross-mixing off-test, implements the analysis of urgent sample.
In this way, according to the present embodiment, in addition to the effect of embodiment 1 and embodiment 2, by for general sample, tight
Insertion process of anxious sample etc., priority is set to each sample by operator in advance, can be based on automatic analysing apparatus set
Fixed priority implements analysis, reduces sample and takes the human errors such as mistake, and effectively runs automatic analysing apparatus.
【Embodiment 5】
Figure 19 is the handling process for the automatic analysing apparatus for showing the embodiment 5 involved by the other embodiment of the present invention
Flow chart.In the present embodiment, this point of Reagent management and above-described embodiment 1 to embodiment 4 are implemented based on pooled plasma sample number
It is different.In addition, the composition and embodiment 1 beyond reagent management method are same to embodiment 4, therefore its explanation omitted below.
In cross-mixing experiment, such as handled 7 measured values as one group of result, therefore for one group of measure, it is necessary to
Ensure its reagent for same batch (being preferably same bottle).When especially measure project is APTT, due to not implementing to calibrate, institute
During with the different reagent of batch, deviation is easily produced in measurement result.In addition, even same batch, is saved in device
The reagent of reagent container (reagent bottle) of the reagent with newly breaking a seal in the reagent container (reagent bottle) of a period of time also can be produced easily
Raw deviation.Herein, in the automatic analysing apparatus of the present embodiment, after the analysis commission for confirming cross-mixing experiment, it is necessary to ensure that energy
Enough reagents at least implementing one group of measure, this puts critically important.As shown in figure 19, (walked after accepting the analysis commission of instant type
Rapid S501), control unit 120 can confirm necessary test number (the pooled plasma number being configured to) and reagent residual.That is, sentence
The fixed relation (step S502) for whether meeting " the remaining test number of pooled plasma sample number≤reagent ".Step S502 result of determination
When exceeding reagent residue test number for "No", i.e. pooled plasma sample number, into step S504, and show and report in display part 118c
It is alert.In addition, when the result of step S502 judgement is tested below number for pooled plasma sample number for reagent is remaining, into step
S503, and implement cross-mixing experiment (implementing analysis).
In addition, control unit 120 can be implemented to control when being provided with the reagent bottle of multiple same projects so that at least at one group
Will not across bottle implementation analysis in measure.For example, the remaining test number of bottle 1 is " 100 times for the remaining test of " 3 tests ", bottle 2
Test " and cross-mixing experiment for 7 points (7 kinds of conditions) commission when, " reagent of pooled plasma sample number (7) >=bottle 1 is remaining
Test number ", therefore cancel the analysis of bottle 1, checked with the remaining test number of bottle 2.During bottle 2, due to " pooled plasma sample number
The remaining test number of the reagent of (7)≤bottle 2 ", so cross-mixing experiment (analysis) can be implemented.Moreover, it is assumed that neither one can
During the reagent bottle analyzed, meeting output system, which is alarmed and cancels analysis, to be started (step S504).
According to the present embodiment, when implementing one group of cross-mixing experiment, reagent deficiency will not occur in analysis midway, can make
Analyzed with the reagent of same bottle.Therefore, it is possible to provide the result of high reliability.
【Embodiment 6】
Figure 20 is the handling process for the automatic analysing apparatus for representing the embodiment 6 involved by the other embodiment of the present invention
Flow chart.In the present embodiment, the compound method of pooled plasma is different from 1~embodiment of above-described embodiment 5.Other, automatic point
The composition of analysis apparatus, the flow of general measuring clotting time are identical with embodiment 1 or embodiment 2, therefore repeat specification omitted below.This
Outside, the compound method on sample, part same as Example 1 can simplify explanation as far as possible.
In above-described embodiment 1 and embodiment 2, consist of, as shown in figure 5, needed for being shown in display part 118c just
Normal plasma volume and to operator avoid that the risk of sample deficiency occurs in midway for examination plasma volume, and by notice.But ten thousand
One because operator error occur normal plasma amount and/or for examination plasma volume deficiency when, can preparation midway occur sample not
Foot, and the sample prepared can be wasted.Therefore, in the automatic analysing apparatus of the present embodiment, even in should prepare as described above
Normal plasma and/or for examination blood plasma occur it is insufficient when, will not also waste sample, can effectively implement to determine.
As shown in figure 20, the commission (step S601) of cross-mixing experiment is accepted in automatic analysing apparatus, and sets measure
After project and normal plasma ratio, analysis operation control part 120a can implement following handle.That is, analysis operation control part
120a can calculate the normal plasma amount needed for measure and supply examination plasma volume, determine mutually different normal plasma respectively according to condition
Measure and for examination plasma volume, and control the action of sample dispensing mechanism 101.
Then, after pressing the START button on the operation screen shown in Fig. 5, analysis operation control part 120a will recognise that this
START button has been pressed (step S602).Then, confirm whether there is sky sample container (step S603).Whether there is sky sample container
Confirmation method it is identical with Fig. 3 step S103 processing (embodiment 1).
In step S604, whether the empty sample container number for judging to obtain by implementation steps S603 is more than N (N is natural number).
In addition, N is set as empty sample container for example corresponding with the normal plasma ratio set on the operation screen shown in Fig. 5 herein
Number i.e. 7.The result of judgement is when the empty sample container of required number is not provided with defined position, to stop sample and prepare, and
(step S605) is alarmed in display part 118c display systems.On the other hand, the result of judgement is to set to have time on defined position
During sample container, into step S606, the liquid level detection function that mechanism 101 is dispensed using sample checks plasma volume.
But the measure number in cross-mixing experiment is recommended to be at least 3.In other words, cross-mixing experiment is more than 3
When, it can implement.Figure 21 represents the display example of the operation screen when commission cross-mixing of the present embodiment is tested.Such as Figure 21 institutes
Show that in cross-mixing tests measure commission picture, there is the region for the priority that can select normal plasma ratio.Figure 21 institutes
In the example shown, it can divide for 3 stages inputted successively from high to low according to priority.That is, in priority level initializing region
The priority of middle setting meets the relation of " the > priority 3s of 1 > priority of priority 2 ".Shown here as by normal plasma ratio
0%th, 50% and 100% is set as priority 1, and normal plasma ratio 10% and 20% are set as into priority 2, will be normal
Plasma ratio 80% and 90% state for being set as priority 3.The priority of these settings can be stored in storage part 119.
In addition, Figure 22 to Figure 24 shows normal plasma amount corresponding with each normal plasma ratio and the relation for examination plasma volume.Such as
Shown in Figure 22, according to 7 kinds of conditions that normal plasma ratio is 0,10,20,50,80,90,100%, the mixed of 200 μ L is made respectively
Close blood plasma, implement cross-mixing experiment when, normal plasma, for examination blood plasma be respectively necessary for more than 700 μ L.Herein, even if illustrating it
One or both of when not meeting aequum, the method that can also utilize less plasma volume to obtain effective analysis result.
Herein, Figure 20 is returned, in step S607, judges whether normal plasma amount is XNIt is above and for examination plasma volume
No is YNMore than.Herein, XNIt is 700 μ L, Y in the example shown in Figure 22NIt is similarly 700 μ L.The result of judgement is " normal blood
Slurry amount >=XN" and " for examination plasma volume >=YN" in some or two do not meet during condition, i.e. plasma volume does not meet aequum
When, step S608 can be entered.
In step S608, for change measure points, with reference to be stored in storage part 119 to the excellent of each normal plasma ratio set
First level, plasma volume will be calculated again except condition corresponding with priority 3.In step S609, determine whether to meet " normal blood
Slurry amount >=(XN-XP3) " and " for examination plasma volume >=(YN-YP3)”.Herein, when being determined under conditions of except by priority 3 just
Normal plasma volume (XN-XP3) it is 360 μ L, supply examination plasma volume (Y when being determined under conditions of except by priority 3N-YP3) it is 640 μ
L (Figure 23).The result of judgement is " normal plasma amount >=(XN-XP3) " and " for examination plasma volume >=(YN-YP3) " in some or
Two when not meeting condition, into step S610.On the other hand, result of determination is when meeting above-mentioned condition, into step S613.
In step S610, except in the only condition of setting priority 1, i.e. by priority 2 and the condition of priority 3
Under the conditions of determine when plasma volume recalculated.Herein, the μ L of normal plasma amount 300 and confession examination plasma volume 300 μ L can conducts
Plasma volume after recalculating obtains (Figure 24).
Then, into step S611, determine whether to meet " normal plasma amount >=(XN-XP3-XP2) " and " for examination plasma volume >=(YN-
YP3-YP2)”.Result of determination is normal plasma amount >=(XN-XP3-XP2) " and " for examination plasma volume >=(YN-YP3-YP2) " in it is a certain
It is individual or when two do not meet condition, into step S612, alarmed to display part 118c output systems, and stop matching somebody with somebody for pooled plasma
System.On the other hand, result of determination is when meeting above-mentioned condition, into step S613.
In step S613, analysis operation control part 120a can control sample dispensing mechanism 101 and reagent dispensing mechanism 106,
And start normal plasma and the dispensing for examination blood plasma.In addition, normal plasma and dispensing and above-described embodiment 1 for trying blood plasma are same
Sample, therefore omit the description herein.After the dispensing of all normal plasmas and confession examination blood plasma completes (step S614), action control is analyzed
Portion 120a can control rabbling mechanism 126, implement the stirring (step S615) of pooled plasma.After pooled plasma stirring, it can implement point
Analysis.
In Figure 20, when being 3 stages by priority level initializing exemplified by be illustrated, but be not limited to this, priority can
Any setting.
According to the present embodiment, in addition to the effect of above-described embodiment 1 and embodiment 2, even if not meeting with setting originally
Normal plasma ratio corresponding to measure needed for normal plasma amount and/or for examination plasma volume when, can also obtain effective friendship
Pitch mixed determining result.
In addition, the present invention is not limited to above-described embodiment, various modifications example is included.For example, in order in the explanation present invention
When be understood that, be described in detail by above-described embodiment, but be not limited to possess illustrated all structures.This
Outside, the part-structure of a certain embodiment can be replaced with to the structure of other embodiment, can also be by the structure of a certain embodiment
Added in the structure of other embodiment.Further, it is also possible to the part-structure of each embodiment is deleted or adds, replace it
The structure of his embodiment.
Label declaration
100 automatic analysing apparatus
101 samples dispense mechanism
101a samples dispense probe
102 sample disks
103 sample containers
104 reaction vessels
105 sample syringe pumps
106 reagents dispense mechanism
106a reagents dispense probe
107 reagent discs
108 reagent containers
108a reagents
109 reagent heating-up mechanisms
110 reagent syringe pumps
111 reaction vessel storage units
112 reaction vessel transport mechanisms
113 detection units
114 reaction vessel setting units
115 light sources
116 test sections (light accepting part)
117 reaction vessel waste parts
118 operating portions
118a mouses
118b keyboards
118c display parts
119 storage parts
120 control units
120a analyzes operation control part
120b operational parts
121 A/D converters
122 interfaces
123 printers
124 insulating boxs
125 reading parts
126 rabbling mechanisms
127 inspection project selections/designated area
201 sample racks
202 sample rack supply units
203 sample rack incorporating sections
204 carrying lines
205 lines of return
206 sample rack standby unit
207 standby unit operating mechanisms
208 sample rack gigbacks
209 the 1st reading parts (carrying line)
210 analysis portions
211 the 2nd reading parts (analysis portion)
212 the 1st sample rack operating mechanisms
213 dispensing lines
214 buffer regions
215 the 2nd sample rack operating mechanisms.
Claims (20)
1. a kind of automatic analysing apparatus, it is characterised in that possess:
Sample dispenses mechanism, and it is by for examination blood plasma and/or to correct the normal blood that the setting time for trying blood plasma is added
Slurry is dispensed to multiple sample containers;
Reaction vessel, it prepares only described for examination blood plasma, only described normal plasma and with least one kind of in the sample container
The pooled plasma mixed for trying blood plasma and normal plasma is utilized dispensing institute of sample dispensing mechanism by mixing ratio
State confession examination blood plasma, the normal plasma and the pooled plasma being formulated;
Reagent dispenses mechanism, and it dispenses reagent to the reaction vessel;And
Determination part, it in the reaction vessel to the addition of the described for examination blood plasma, normal plasma and/or pooled plasma of reagent
Irradiate the light from light source, and the scattering light based on acquisition and/or transmission light measurement setting time.
2. automatic analysing apparatus according to claim 1, it is characterised in that
With sample disk, it is annular in shape and houses separated from each other described for examination blood plasma, the normal plasma and the mixing
Blood plasma.
3. automatic analysing apparatus according to claim 1, it is characterised in that possess:
Sample rack, it is described for examination blood plasma, the normal plasma and the pooled plasma for housing;
Sample rack supply unit, it is used for housing multiple sample racks;
Carrying line, it is used for from the sample rack supply unit transporting the sample rack to the determination part;And
The line of return, it transports the sample rack to sample rack incorporating section from the determination part.
4. automatic analysing apparatus according to claim 1, it is characterised in that
With display part, it, for examination blood plasma, the normal plasma and the pooled plasma, is shown for described with graph mode
The setting time obtained by determination part.
5. automatic analysing apparatus according to claim 4, it is characterised in that
Possesses insulating box, each reaction vessel for housing the pooled plasma is heated the stipulated time by it with set point of temperature.
6. automatic analysing apparatus according to claim 5, it is characterised in that
Reagent is dispensed to being housed in each reaction vessel and after heating stipulated time using reagent dispensing mechanism
It is described in examination blood plasma, the normal plasma and the pooled plasma, and utilize determination part measure setting time.
7. automatic analysing apparatus according to claim 4, it is characterised in that
House be configured to by the sample dispensing machine it is only described for examination blood plasma, only described normal plasma and with described
In the differential responses container for the pooled plasma that at least one kind of mixing ratio is formulated, reagent dispensing mechanism dispensing is utilized
Reagent, and utilize determination part measure setting time.
8. automatic analysing apparatus according to claim 4, it is characterised in that
For described for examination blood plasma, the normal plasma and the pooled plasma, supplied using described in indivedual identification media managements
Try the information of blood plasma, the normal plasma and the pooled plasma.
9. automatic analysing apparatus according to claim 4, it is characterised in that
With level detection mechanism, it confirms for examination plasma volume, normal plasma amount and empty sample container in advance.
10. automatic analysing apparatus according to claim 9, it is characterised in that
For only described for trying blood plasma, only described normal plasma and the pooled plasma with different multiple mixing ratios, in advance
Set priority,
When predicting that deficiency occurs in the confession examination plasma volume and/or the normal plasma amount, based on the priority of the setting, determine
Surely the combination for examination blood plasma, the normal plasma and the pooled plasma of the setting time should be determined.
11. automatic analysing apparatus according to claim 4, it is characterised in that
To the residual of each reagent container management measure object reagent, and the examination used according to the control of the quantity of the pooled plasma
Agent container.
12. automatic analysing apparatus according to claim 4, it is characterised in that
The determination part preferentially determines swiftness high sample.
13. automatic analysing apparatus according to claim 12, it is characterised in that
With operating portion, it is in advance to urgent sample, general sample and containing for determining the described mixed of the setting time
Close the sample setting priority of blood plasma.
14. the automatic analysing apparatus according to claim 10 or 13, it is characterised in that have:
Storage part, it stores each priority;And
Control unit, it implements control so that, will by sample disk or carrying line based on the priority being stored in the storage part
Corresponding sample is transported to the determination part.
15. a kind of automatic analysis method, it is that at least there is sample to dispense the automatic of mechanism, reagent dispensing mechanism and determination part
The automatic analysis method of analytical equipment, it is characterised in that
It will be added just for examination blood plasma and/or to correct the setting time for trying blood plasma using sample dispensing mechanism
Normal blood plasma is dispensed to multiple sample containers,
Prepared in the sample container it is only described for examination blood plasma, only described normal plasma and with least one kind of mixing ratio by institute
The pooled plasma mixed for examination blood plasma and normal plasma is stated,
By it is described make it is described housed for examination blood plasma, the normal plasma and the pooled plasma to reaction vessel, together
Reagent dispensing mechanism dispenses reagent to the reaction vessel described in Shi Liyong,
The described of reagent that with the addition of in the reaction vessel is come from for examination blood plasma, normal plasma and/or pooled plasma irradiation
The light of light source, and the scattering light based on acquisition and/or transmission light measurement setting time.
16. automatic analysis method according to claim 15, it is characterised in that
By for each setting time drafting pattern obtained for examination blood plasma, the normal plasma and the pooled plasma
Table, and show to display part.
17. automatic analysis method according to claim 16, it is characterised in that
Each reaction vessel for examination blood plasma, the normal plasma and the pooled plasma will be housed at an established temperature
Heat the stipulated time,
Reagent is dispensed into the reaction vessel after the heating stipulated time, determines setting time.
18. automatic analysis method according to claim 16, it is characterised in that
For only described for trying blood plasma, only described normal plasma and the pooled plasma with different multiple mixing ratios, in advance
Set priority,
Based on the priority of the setting, determine to determine the setting time it is described for examination blood plasma, the normal plasma with
And the combination of the pooled plasma.
19. automatic analysis method according to claim 16, it is characterised in that
In advance to urgent sample, general sample and containing being set for determining the sample of the pooled plasma of the setting time
Determine priority,
The order analyzed according to the priority change of the setting.
20. a kind of automatic analysing apparatus, it is characterised in that possess:
Multiple sample containers, it is housed only for trying blood plasma, only normal plasma and supplying to try by described with least one kind of mixing ratio respectively
The pooled plasma that blood plasma and normal plasma mix;
Individual identification media, it is attached in each sample container, and storage is used for identifying the sample housed in the sample container
Information;
Reading part, it reads the information being stored in the individual identification media;
Sample dispenses mechanism, and it will be only described for trying blood plasma, only normal plasma and pooled plasma respectively from the multiple sample
Container is dispensed into reaction vessel;
Reagent dispenses mechanism, and it dispenses reagent to the reaction vessel;
Determination part, the described of reagent that with the addition of in the reaction vessel is shone for examination blood plasma, normal plasma and pooled plasma
Penetrate the light from light source, and the scattering light based on acquisition and/or transmission light measurement setting time;
Operational part, it is based on obtaining by the determination part described for examination blood plasma, just after the pooled plasma is just mixed
The measurement result of normal blood plasma and pooled plasma, draws the instant type figure for showing the mixing ratio and the relation of the setting time
Table, and in the mixing from the pooled plasma after the stipulated time, it is described for trying based on being obtained by the determination part
The measurement result of blood plasma, normal plasma and pooled plasma, draw and show the mixing ratio and the relation of the setting time
Delaying type chart;And
Display part, it is overlapping to show the described instant of same sample group based on the information being stored in indivedual identification media
The chart of type and the delaying type.
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
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CN202210743922.6A CN115112910A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210743939.1A CN115112911A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210743918.XA CN115128290A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210773764.9A CN115144603A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210773763.4A CN115144602A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210773749.4A CN115144601A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210741895.9A CN115407072A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
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JP2015057503 | 2015-03-20 | ||
JP2015-057503 | 2015-03-20 | ||
PCT/JP2016/054058 WO2016152305A1 (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
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CN202210773764.9A Division CN115144603A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210743939.1A Division CN115112911A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210773763.4A Division CN115144602A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210743918.XA Division CN115128290A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210741895.9A Division CN115407072A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210773749.4A Division CN115144601A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
CN202210743922.6A Division CN115112910A (en) | 2015-03-20 | 2016-02-12 | Automatic analysis device and automatic analysis method |
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US20200326353A1 (en) | 2020-10-15 |
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JP2019215357A (en) | 2019-12-19 |
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